Comparative Analysis of Key Market Access Dossiers: How Global, European, German, and United States Dossier Formats Compare in Terms of Structure, Timing, and Application

OBJECTIVES: Introduction of the European Joint Clinical Assessment (JCA) in 2025 presents a new hurdle for manufacturers amid other launch preparations. We compared the JCA template with established formats for German benefit assessment, US formulary submission, and a typical global value dossier (GVD) to identify potential development efficiencies.

METHODS: Evaluations focused on structure, content, level of detail, and timing. Commonalities between dossiers were rated as high/moderate/low.

RESULTS: The JCA and German dossiers exhibit high commonality in structure, content, and detail level; moderate similarity with the AMCP dossier and less with the more flexibly formatted GVD.

All four dossiers characterize the target condition and population, the product, and its clinical benefits in terms of efficacy, safety, and comparative effectiveness. While all include supporting information like clinical guidelines and treatment pathways, evidence requirements are more extensive for JCA and German dossiers.

Differences include perspectives: global (GVD), regional (JCA) or national (Germany, US). Inclusion of economic evidence also varies: JCA excludes economic data; the German dossier focuses on statutory health insurance costs; AMCP on budget impact, GVDs on cost-effectiveness and budget impact models. GVD content can be derived from targeted literature reviews, whereas others require evidence to be identified systematically.

A unique requirement for JCA includes presentation of comparative effectiveness by population-intervention-comparators-outcomes (PICOs), epidemiology and treatment pathways for all 27 member states. The German dossier requires subgroup analysis for all endpoints (including age, gender, severity, region) and only considers the G-BA-defined appropriate comparator. The AMCP dossier addresses health-equity issues. GVDs are internal documents, including clear guidance on value messaging and strategy.

Timings for completion vary, with more flexibility for GVDs and AMCP dossiers than JCA and German dossiers.

CONCLUSIONS: Content overlap between dossiers offers potential development efficiencies. However, unique requirements and perspectives require tailored approaches for each rather than simple conversions.